Regulatory Affairs Manager

integratedresourcesinc
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šŸ“ LexingtonšŸ“ Lexington, MA, United StatesšŸ“ MAšŸ“ usContract

About this role

Company Description

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Client Direct Client

Location Lexington, MA

Job Title Regulatory Affairs Manager

Duration 6+ Months

Must have skill-set [Job Description] Job Function and Description:

ā€¢ Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.

ā€¢ Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.

ā€¢ Develop regulatory submission strategies in agreement with defined product development objectives. ā€¢ Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects.

ā€¢ Prepare and submit IND and NDA applications, as well as various amendments and supplements.

ā€¢ Prior management experience, with a demonstrated capability to lead and motivate staff is essential.

ā€¢ Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical. Experience Requirements:


Qualifications

ā€¢ Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.

Additional Information

Thanks!!!

Warm Regards,

Amrit Singh

Clinical Recruiter Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Tel: (732) 429 1634

Fax: (732) 549 5549

http://www.irionline.com Inc.

Ā 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70










Frequently Asked Questions

Is the salary disclosed for the Regulatory Affairs Manager position at integratedresourcesinc?
The salary for this Regulatory Affairs Manager role at integratedresourcesinc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Manager position at integratedresourcesinc located?
This Regulatory Affairs Manager role at integratedresourcesinc is based in Lexington, Lexington, MA, United States, MA, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs Manager role at integratedresourcesinc full-time or part-time?
This is listed as a Contract position. It is posted as a Regulatory Affairs Manager role at integratedresourcesinc.
How do I apply for the Regulatory Affairs Manager position at integratedresourcesinc?
Click the "Apply Now" button on this page. You will be redirected to integratedresourcesinc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Regulatory Affairs Manager job at integratedresourcesinc posted?
This Regulatory Affairs Manager position at integratedresourcesinc was posted on Mar 25, 2015. Apply as soon as possible ā€” early applications are often reviewed first.
Regulatory Affairs Manager
integratedresourcesinc
Apply for this role ā†—

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